This section is intended for Argus Interchange Administrators. The flowchart shows the steps to follow when configuring, reviewing, and administering Argus Interchange.
The Argus Interchange Mapping Utility enables you to store multiple profiles. This enables companies to transmit E2B reports to multiple agencies. The Argus Interchange Mapping Utility maintains an audit log that tracks every change made to the settings. You can also use this utility to view Trading Partner Configurations. This chapter includes discussions of the following:
This section provides information about a logging in and out of Interchange.
To log on to Interchange:
Go to Start-->Programs-->Oracle-->ESM Mapping.
Enter the User Name, Password, and Database in the log on dialog.
Note: The User Name and Password for the ESM Mapping Utility are created through User Configuration in the Web Console. This is done by enabling the ESM Admin checkbox for the user. |
Click Login.
This section provides information about working with profiles and includes discussions of the following:
Defining a Profile
Printing a Profile
Copying a Profile
Deleting a Profile
This section describes how to view or modify the rules of a DTD profile in Argus Interchange Mapping Utility. You can view profile details by selecting a Profile from the Argus Interchange Mapping Utility window.
The following table lists and describes items that are common to each tab of the Argus Interchange Mapping Utility.
Item | Description |
---|---|
Profile | Displays the E2B Report structure. Profiles define the rules used to generate and import E2B reports.
ICH, EMEA and FDA are the three main pre-defined profiles. Custom profiles are created after copying from the existing profiles. The details of the factory DTD profiles are read-only. Only custom profiles can be edited. PMDA - I and PMDA - J profiles are also provided as pre-defined profiles for PMDA E2B reports. |
Left Pane | Displays the hierarchy of the elements of the DTD Profile. |
The following is an illustration of the Transmit tab.
To view details in the Transmit Tab:
Select a profile from the Profile drop-down list.
Click Transmit.
The following tables lists and describes the items on the Transmit tab:
Item | Description |
---|---|
Adverse Event Database Select Statement | Enables you to enter and view the SQL logic used to extract the value of the selected element of the DTD profile from AE database. |
E2B Check checkbox | Indicates whether the selected profile is used in the E2B check functionality in Argus.
The E2B check function is used to validate E2B reports based on the validation rules defined for the DTD profiles. Only the profiles that have the E2B check selected are used for validation. |
This tab is only enabled for PMDA (Pharmaceuticals and Medical Devices Agency) profiles and is not displayed EMEA or FDA profile. The following table describes the fields available on the Japanese DTD tab for the Factory PMDA profile:
Field | Description |
---|---|
Field Location | This field contains the UI field location till the section level from Argus Case Form or Argus Console. This field is editable only for non-factory profile. |
Field Name | This field contains the UI Field Label either from Argus Case Form or Argus Console. This field is editable only for non-factory profile. |
Allow Japanese Characters | This drop-down is available at element level and not reporting category level. It contains the following values:
This field is editable only for non-factory profile. |
Reporting Category: | This column contains the read-only Reporting Category values. These values are retrieved from the Reporting Category code list dynamically. |
Reporting Category Desc. | This column contains read-only text specifying the description of the corresponding Reporting Category. This value is retrieved from the Reporting Category code list. |
Reporting Category Validation | All the five Japanese validation types that are available in this drop-down are described below:
These values are picked up from an internal table. These values are pre-defined for the factory defined profile. This field is editable only for non-factory profiles. |
This section describes how to setup your printer and print the profile.
You should set up your printer before printing a profile.
To set up your printer
Select Administrator -> Printer Setup to open the Printer Setup dialog box.
Select the default printer from this dialog box.
The following is an illustration of the Print dialog box.
Use the following procedure to print a profile.
Select Administrator -> Print Profile.
This prints the selected profile to your default printer.
The following is an illustration of a printed profile.
Use Print Profile option to print the profile details available on the Japanese DTD tab.The following sections are not printed in a profile, if it is not a PMDA profile:•Legend for PMDA ICSR Validation Rules•Japanese DTD Details
Use the following procedure to copy a profile.
In the Profile list, select the profile to copy.
Select Administrator -> Copy Profile, to open the Copy Profile dialog box.
Type the profile name in the To Profile field, click Save, and click OK.
You can only delete profiles created or modified in the Interchange Mapping Utility interface. You cannot delete the pre-installed Argus Interchange profiles.
To delete a profile
Select the profile to delete from the Profile list.
Select Administrator -> Delete Profile.
Click Yes to confirm the deletion of the profile.
Use the following procedure to view regulatory authorities/trading partners.
Select Administrator->Trading Partners to open the Agency List dialog box.
Double-click the required Regulatory Authority or Trading Partner to view its details.
The system opens the Trading Partner Configuration dialog box. You cannot modify the information in the dialog box.
Note: To modify or create new Regulatory Authorities/Trading Partners, choose Reporting Destination in the Code List in Argus Console. |
You can configure the Argus Interchange Service by updating the initialization (INI) file from the Argus Interchange Mapping interface.
To configure Argus Interchange Service:
Select Administrator -> Setup INI File menu in the Interchange Mapping Utility to open the Service INI File Setup dialog box.
Use the items in the Service INI File Setup dialog to configure the Argus Interchange Service INI file.
Enter the data for each field as required.
The following tables lists and describes the fields in the Service INI File Setup dialog box.
Item | Description |
---|---|
IT E-mail | Enter the e-mail address the Argus Interchange Service should use if the transmit time out occurs for Physical Media or EDI Gateway. |
Business E-mail | Enter the e-mail address where the Argus Interchange Service should send a message to the Receive ACK time-out value is reached |
User E-mail | Enter the e-mail address where the Argus Interchange Service where can send a message when the user does not process the E2B Report within the time-out value. |
Lotus Notes/ MAPI/ SMTP | Select the Mail System that the Argus Interchange Service will use. |
Profile Name | Enter the MAPI Profile name of the e-mail account. |
Lotus Notes Password | Enter the Lotus Notes Client password.
The system encrypts this password and saves it in the ESMService.ini file. The Argus Interchange Service uses Lotus Notes to send an e-mail message even if the password is set on Lotus Notes client. |
EDI Software Name | Enter the EDI software name (i.e., Cyclone). |
EDI Database Name | Enter the database name for the EDI software. |
EDI User ID | Enter the user name for EDI database. |
EDI Password | Enter the password for the user name associated with the EDI database. |
EDI Client Software | Enter the type of database used by the EDI software (Example: Oracle, MSSQL) |
DTD Path | Enter the path for the DTD file. |
Log File Path | Enter the path where the Argus Interchange Service will write the log files. |
Documentum Type | The Documentum table. |
User Name | The user name the Argus Interchange Service uses to log on to Documentum. |
Multiple Database Section | Displays all the configured databases for ESM Service. |
Delete Button | Click Delete to remove the entire Database Configuration from ESM Service INI File. |
You can configure the Argus Interchange Service to support multiple database.
To configure a database:
In the Setup INI File dialog box, double click Add New Process to open the Service DB Setup dialog.
Use the items in the Service DB Setup dialog to configure the ESM Service INI file.
Enter the data in the fields as required.
The following table lists and describes the fields in the Service DB Setup dialog box.
Item | Description |
---|---|
Database Name | Enter the name of the Adverse Event database. |
Unique Database ID | Identifies each database uniquely. In the case of multiple databases, the value of this field should be unique. |
User ID | Enter the user name for the Service. |
Password | Enter the password associated with the User Name entered in the USER ID field. |
Process | Enter the full path of the ESMProc.exe file. The system uses this path to locate the ESMProc.exe file. |
Receive Process | Enter the full path of the E2BReceive.exe file. The system uses this to locate the E2BReceive.exe file. |
Archive Folder | Enter the full path where the system places the file processed by Argus Interchange. |
Receive Processes Count | Enables you to specify multiple E2B receive processes
You can specify from 1 to 5 E2B receive processes The default is 1. |
Process Elapse Time | Enter the time interval for the Argus Interchange Process to run. |
Enter EDI Transmit Time out Value | The amount of time, in minutes, that must pass before the system sends an e-mail message when an E2B Report has not been transmitted within a specified time period.
Note: The minimum value for the time-out is 10 minutes. |
Enter Physical Media Transmit Time out Value | Enter amount of time, in minutes, that must pass before the system can send an e-mail message when an E2B Report has not been sent manually by a specified person within a specified time period.
Note: The minimum value for the time-out is 10 minutes. |
Enter Receive ACK Time Out Value | Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when an ACK message has not been received within a specified time period.
Note: The minimum value for the time-out is 10 minutes. |
Enter Processing Time Out Value | Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when an Incoming Report has not been processed within a specified time period.
Note: The minimum value for the time-out is 10 minutes. |
Enter XML Transmit Time Out Value | Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when an XML file is not picked up by the Gateway.
Note: The minimum value for the time-out is 10 minutes. |
Enter Binary Transmit Time Out Value | Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when a binary file is not picked up by the Gateway.
Note: The minimum value for the time-out is 10 minutes. |
Enter MDN Time Out Value | Enter the amount of time, in hours, that must pass before the system stops polling the MDN information from the EDI server after receiving the Business ACK for a transmitted report. |
Agency Name | Select the Agency from the drop-down list.
Note: Green Checked rows have already been configured while Red checked rows have not been configured. |
Local Company | The system automatically populates this field when Agency is selected. |
EDI Incoming Folder Name | Enter the path to the folder where incoming files are stored. |
EDI Outgoing Folder Name | Enter the path to the folder where outgoing files are stored. |
XML Incoming Folder | Enter the path to the "xmlin" folder in the company profile directory.
Note: This step is necessary to ensure correct EMEA submissions. |
XML Outgoing Folder | Enter the path to the "xmlout" folder in the company profile directory.
Note: This step is necessary to ensure correct EMEA submissions. |
Binary Incoming Folder | The folder where the system stores the incoming binary files (like PMDA Zip file) or acknowledgements received for the transmitted binary files from the regulatory authority/trading partner.
EDI Gateway places the files in this folder and Argus Interchange Service picks these files from here. |
Binary Outgoing Folder | The folder where the system stores the binary files (like PMDA Zip file or E2B Attachments) or Acknowledgement files for incoming binary files to be transmitted to the regulatory authority/trading partner.
Argus Interchange Service places the files in this folder and EDI Gateway retrieves and transmits them to the appropriate regulatory authority. |
Physical Incoming Folder | Enter the path to the folder where the incoming physical media files will be stored.
Note: This folder must be created manually; the system does not create it automatically. |
Physical Outgoing Folder | Enter the path where the Outgoing Physical Media Files will be stored.
Note: This folder needs to be created manually; the system does not create it automatically. |
Save Button | Click Save set the Folder Paths configured for the Agency as Default. When selecting another agency to configure from the Drop Down, all the Paths will remain. |
Delete Button | Click Delete to delete the entire configuration for the Agency selected only. |
The audit log stores changes made to the system from the application in the audit log. You can also view and filter individual changes.
To view the audit log:
Select Administrator -> Audit Log.
When the system opens the Audit Log dialog box, enter the appropriate data in each field and click Search.
When the system displays the search results, double-click a row to view detailed information about the changes made in the Audit Log Detail dialog box.
Select an item in the list at the bottom of the Audit Log Details dialog to view details of the old value and the new value of the selected item.
The following table lists and describes the fields in the Audit Log dialog box.
Item | Description |
---|---|
From | Enter the search start date. |
To | Enter the search end date. |
Range | Select a pre-configured date range on for the search.
Note: When the Argus Interchange Audit log is invoked, it shows the default range of the last 7 days. |
User's List | Select a user from the list of users. |
Print Log | Prints the current view. |
Search | Performs the search. |
Close | Closes the dialog. |
You can compare two DTD profiles to find element-level differences. Select a source profile in the left pane and a target profile in right pane and run the Compare Profiles utility to generate the differences. The Compare Profiles utility also enables you to update the SQL statements (at the element level) of the Destination Profile elements with those of the Source Profile.
To compare DTD profiles:
On the Argus Interchange Mapping Utility menu bar, click Administrator -> Compare Profiles.
When the system opens the Compare Profiles dialog box, use the items in the Compare Profiles dialog to compare profiles.
Enter the data in the files as required.
The following table lists and describes the fields in the Compare Profile dialog box.
Item | Description |
---|---|
Source Profile drop-down | Is used for selecting a source profile from the available profiles configured in the system. |
Destination Profile drop-down | Displays the profiles with the same DTD version and type (message/acknowledgement) as the ones in the Source profile.
Note: The source profile is to be selected before selecting the destination profile. The destination profile is disabled if you have not selected the source profile. |
Show Difference Only | Displays those nodes that contain different SQL statements between the source and destination profiles when this checkbox is checked. |
Compare | Compares the differences between the source and destination profiles when this button is clicked.
Note: The elements that are different in the Source and Destination profiles are displayed in a light gray background color. |
Source Profile pane | Displays the source profile and its elements in a tree structure. When you click on any of the elements, the corresponding SQL statements are displayed on the source profile textbox, which is on the left-corner below the Source Profile pane. |
Destination Profile pane | Displays the destination profile and its elements in a tree structure. When you click on any of the elements, the corresponding SQL statements will be displayed on the Destination profile textbox, which is on the right-corner below the Destination Profile pane. |
Prints all the SQL statements of the source and the destination profile with differences highlighted.
Note: If there are no differences between the source and destination profiles, the following pop-up message is displayed: "No differences found' and no report shall be printed." |
|
Update | Updates the individual SQL statements related to each element. Clicking the Update button also updates SQL statements in the destination profile.
Note: The Update button is enabled when the nodes with different SQL statements are clicked. |
Update All | Updates all the differences in SQL statements across all the elements between the source and destination profiles.
Note: When a user clicks the Update All button, the following pop-up message is displayed: "Are you sure you want to update all the SQL statements in Destination Profile with Source Profile?" Clicking Yes updates all the SQL statements whereas clicking No does not update. |
Close | Closes the Compare Profiles window. |
Note: The Update and Update All buttons are never enabled when the profile selected from the Destination Profile is of the type template. |
E2B Codes Translation enables you to configure rules to translate the E2B codes and values in the incoming E2B reports, which come from different trading partners to preferred values in the AE system during case creation.
In the Interchange Mapping Utility, click Administrator -> E2B Translation Codes to open the E2B Code Translation screen.
The following table lists and describes the fields on the E2B Codes Translation screen.
Item | Description |
---|---|
Agency Name | Enables the user to select an agency name from the drop-down list box. |
# |
Displays the serial number. |
DTD Element Name | Displays the DTD element name. |
Input Value | Displays the type of input value |
Output Value | Displays the type of output value. |
Edit | Enables you to edit the information |
Use the following procedure to configure E2B Codes Translation.
Select the Agency Name from the drop-down list box to displays the DTD Elements and their descriptions.
Click Edit to edit the DTD Element Name, Input Value, Output Value, and DTD Element Description.
Click Save to save your changes.
You can use the existing reporting destination configuration to choose an extended E2B profile. The system uses the agency and company identifier to identify the profile to use and sends the information in the following XML elements:
<messagesenderidentifier>Company X</messagesenderidentifier>
<messagereceiveridentifier>Agency Y</messagereceiveridentifier>
The Interchange mapping utility also supports the defined extended E2B elements as follows:
A switch in the Interchange mapping tool identifies a profile as either a standard profile or an extended E2B profile but only for the Receive tab. The additional fields are formatted as follows:
<XXX>_EXTENSION []
where:
XXX is the tag name followed by _EXTENSION to indicate that this is an extended E2B tag element
When using this switch:
Do not enter any blank spaces or underscore characters ( _ ) in the XXX naming convention.
In the extended E2B tags, the element number in the brackets ( [ ] ) is always empty. For example, Patient Ethnicity, Event Hospitalized Start Date / Stop Date.
This switch is enabled only for profiles copied from the Factory profiles (default unchecked). This flag is disabled for all factory profiles.
During configuration, GPS updates the DTD profile with this information before it adds any additional E2B elements.
The system maps extended E2B fields are mapped to existing Argus fields or to user-defined fields, as appropriate. For example, the system maps the following extended E2B fields to the following Argus tables.
E2B + Field | Argus Case Form UI Field Name | Argus Field Label Description |
---|---|---|
patientethnicity_extension | PATIENT | Patient Ethnicity | Patient Ethnicity |
reactionintensity_extension | EVENTS | Event Intensity | Event Intensity |
reactionhospstartdateformat_extension | Argus Date entry format YYYYMMDD or YYYYMM or YYYY | Hospitalized Start Date Format |
reactionhospstartdate_extension | EVENTS | Hospitalized Start Date | Hospitalized Start Date |
reactionhospstopdateformat_extension | Argus Date entry format YYYYMMDD or YYYYMM or YYYY | Hospitalized Stop Date Format |
reactionhospstopdate_extension | EVENTS | Hospitalized Stop Date | Hospitalized Stop Date |
The system sends an acknowledgement if the message import is successful and a rejection if the message import is not successful.
You can view the extended elements for the following:
E2B Viewer
No updates to the CIOMS / MedWatch Reports
The Decoded View / SGML View displays the additional elements added as a part of the Extended E2B
E2B Difference Report
When imported, the system displays the additional fields in the current difference report viewer.
E2B Selective Intake for Initial and Follow up E2B Reports
You can selectively import the additional fields the system adds to the Extended E2B in the Argus case.
The PDF reports display the additional fields added to the Extended E2B.
The E2B Warnings/Errors display the warnings/errors if warnings or errors defined for the fields added to the Extended E2B.
The Web Console enables you to configure the Regulatory Authorities to which E2B Reports need to be submitted. In accordance with ICH Guidelines, you can configure additional Code List items with new E2B codes.
This section includes discussions of the following:
Configuring Regulatory Authorities
Configuring SMTP
Configuring Code List Items
Transmitting E2B reports to an Agency/Trading Partner, requires you to create a regulatory authority entry in the Code List. After creating the regulatory authority, you can transmit regulatory reports to it.
To configure a regulatory authority:
On the Argus Console, Click Code Lists -> Argus.
When the system opens the Code List Maintenance screen, select Reporting Destination from the list.
Note: If a report has already been generated for a Regulatory Authority, the system disables the Delete button in the Code List dialog box for the particular Regulatory Authority. However, it is still possible to modify these reports there. |
Refer to the Argus Safety Guide for information on using the first three tabs of the Reporting Destination.
Click the EDI tab, select the appropriate data for each item, and enter the data in the fields as required.
The following table lists and describes the fields on the EDI tab.
For Argus J users, an additional field called "Message Profile 2" shows up for the configuration of the PMDA - J profile. This field is required for PMDA agency to specify PMDA J profile.
Field | Purpose |
---|---|
SGML/XML | Enables you to select whether to send the report in SGML or XML format. |
Mark as Auto Submit | Enables you to mark the report for auto submission. |
Imported Cases are assigned to | Enables you to select the country where imported cases need to be assigned.
Note: This list contains the configured Argus sites. The default value is the site of the importing user. |
Initial Workflow State | Enables you to configure the initial workflow state for the case.
Note: This list contains Argus workflow states. The default value is blank. If you select blank as the workflow state, the system treats the case as a new case being booked-in. |
Agency Identifier | Enables you to enter the routing ID configured in Cyclone for the sender community. |
Identification Code | Enables you to enter the agency Duns code, a unique code that identifies a trading partner. |
Code Qualifier | Enables you to enter the code qualifier. The system uses the code qualifier to interpret the identification code. |
XML Source Classification | Defines the E2B source file classification during the E2B import. The system populates this drop-down from the Attachment Classification code list. |
Selection Source Classification | Defines the classification of the PDF for initial intake or the difference report during E2B import. The system populates this drop-down from the Attachment Classification code list. |
Message Profile | Enables you to select a message profile. |
ACK Profile | Enables you to select the acknowledgement profile. |
Primary Receive Agency | Indicates that this is the primary agency receiving E2B reports. |
Auto Accept ICSR's | Enables or disables the auto-accept E2Bs for the agency. |
Transmit E2B Attachments | Enables or disables transmission of E2B attachments for the agency. |
Identification Code | Enables you to enter the company Duns code, a unique code that identifies a trading partner. |
Company Identifier | Enables you to enter the company identifier. |
Code Qualifier | Enables you to enter the code qualifier. The code qualifier is used to interpret the identification code. |
File Name | Enables you to enter the file name |
SGML Declaration File | Enables you to enter the SGML Declaration File. |
Maximum # of reports to include in the msg | Enables you to enter the maximum number of reports that will be transmitted in one message. |
Method | Enables you to select a method. This field contains E2B-EDI Gateway, E2B Physical Media, and E2B-XML Transmission values. |
EDI Header | Enables you to generate the EDI Header |
XML Version | Enables you to enter the XML Version. |
URL of Message DTD | Enables you to enter the path where the message DTD resides on the Internet or to enter the full path, if it is located on the disk. |
Encoding | Enables you to select the character set encoding used in XML |
URL of ACK DTD | Enables you to enter the path where the ACK DTD resides on the Internet or enter the full path, if it is located on the disk. |
Note: In the File Name field, be sure to enter the appropriate naming convention followed by "####" before the transmission extension. |
Argus Interchange Mapping Utility can be configured to send emails to notify the appropriate people on the occurrence of some incidents or errors while processing E2B reports. These emails are sent using Argus Safety Service. You can use Argus Console if you need to configure these emails to be sent using SMTP.
To enable Argus Safety Service to use the SMTP protocol to send e-mail to the e-mail server, use the SMTP Configuration Utility in the following way.
To configure SMTP:
Open Argus Console.
When the system opens the Code List Maintenance screen, click System Configuration -> SMTP Configuration.
When the system opens the SMTP Configuration dialog box, enter the appropriate data in each field.
The following tables lists and describes the fields in the SMTP Configuration dialog box.
Item | Description |
Server IP or Name | The SMTP server IP address or name. |
Port | The port number. The default port number is 25. |
Authentication | The authentication type to use.
Basic Authentication -- The user must enter a user name and password in the Username and Password fields. No Authentication -- The Username and Password fields are disabled. NTLM Authentication, the authentication of the OS user logged into the system is automatically passed. Additionally, the Username and Password fields are disabled in this authentication. |
SMTP Username | The SMTP username. |
SMTP Password | The SMTP password. |
Enable SMTP? | Select this check box to ensure that AG Service uses SMTP to send e-mail. |
Argus Safety is currently shipped with E2B Codes for the applicable factory data items. If you enter new items, E2B codes must be derived from ICH guidelines and entered as described here.
Note: From Argus Console, click Code Lists -> Argus to open the Code List Maintenance screen. |
Use the following procedure to configure action taken:
From the Argus Console, select Code Lists -> Argus -> Action Taken.
When the system opens the Code List Maintenance screen, click Action Taken in the Code List in the left pane.
The system puts the corresponding data for the selected item in the right pane.
Click Add New and enter the E2B code for the new action in the Add New Action Taken section.
Click Save.
Use the following procedure to configure age groups:
From the Argus Console, select Code Lists -> Argus -> Age Groups.
When the system opens the Code List Maintenance screen, locate and click Age Groups in the Code List in the left pane.
The system places the corresponding data for the selected item in the right pane.
Click Add New and enter the E2B Code for the new age group in the Add New Age Groups section.
Click Save.
Use the following procedure to configure age units.
From the Argus Console, select Code Lists -> Argus -> Age Units.
When the system opens the Code List Maintenance screen, click Age Units in the Code List in the left pane.
The system places the data for the selected item in the right pane.
Click Add New and enter the E2B Code for the new age unit in the Add New Age Units section.
Click Save.
Use the following procedure to configure attachment classifications:
From the Argus Console, select Code Lists -> Argus -> Attachment Classification.
When the system opens the Code List Maintenance screen, click Attachment Classification in the Code List in the left pane.
The system places the data for the selected item in the right pane.
Click Add New and click the E2B Additional Doc check box in the Add New Attachment Classification section.
Click Save.
Use the following procedure to configure dosage units:
From Argus Console, Code Lists -> Argus -> Dosage Units.
When the system opens the Code List Maintenance screen, click Dosage Units in the Code List in the left pane.
The system places the data for the selected item in the right pane.
Select an existing Dosage Unit and enter the new E2B code in the Modify Dosage Units section.
Click Save.
Use the following procedure to configure an Event Outcome:
From the Argus Console, select Code Lists -> Argus -> Event Outcome.
When the system opens the Code List Maintenance screen, click Event Outcome in the Code List in the left pane.
The system places the data for the selected item in the right pane.
Enter the E2B Code for the new event outcome in the Add New Event Outcome section.
Click Save.
Use the following procedure to configure Gender.
From Argus Console, select Code Lists -> Argus -> Gender.
When the system opens the Code List Maintenance screen, click Gender in the Code List in the left pane.
The system places the data for the selected item in the right pane.
Enter the E2B Code for the gender in the Add New Gender section.
Click Save.
Use the following procedure to configure Report Type:
From the Argus Console, select Code Lists -> Argus -> Report Type.
When the system opens the Code List Maintenance screen, click Report Type in the Code List in the left pane.
The system places the data for the selected item in the right pane.
Enter the E2B code for the new report type in the Add New Report Type section.
Click Save.
Use the following procedure to configure Reporter Type:
From the Argus Console, select Code Lists -> Argus -> Reporter Type.
When the system opens the Code List Maintenance screen, click Reporter Type in the Code List in the left pane.
The system places the data for the selected item in the right pane.
Enter the E2B Code for the new reporter type in the Add New Reporter Type section.
Click Save.
Use the following procedure to configure Routes of Administration:
From the Argus Console, select Code Lists -> Argus -> Routes of Administration.
When the system opens the Code List Maintenance screen, click Routes of Administration in the Code List in the left pane.
The system places the data for the selected item in the right pane.
Enter the E2B Code for the new route of administration in the Add New Routes of Administration section.
Click Save.
Use the following procedure to configure a Message Type:
From the Argus Console, select Code Lists -> Argus -> Message Type.
When the system opens the Code List Maintenance screen, click Message Type in the Code List in the left pane.
The system places the data for the selected item in the right pane.
Enter the new message type and other relevant data in the Modify Message Type section.
Click Save.
When you select E2B Length Check, the system generates a report that prints the code list item length check and M2 validation warnings. This menu item has been added under Argus Console -> Tools -> E2B Length Check.
The following table lists the Code List items the length check is run on.
Sr. No. | LM Field | Argus Field Length | DTD Allowed Length |
---|---|---|---|
1 | Clinical Studies | Study Information |Study Description.
The application needs to consider the EUDRA-CT length (35) while displaying the message. |
2000 | 100 |
2 | Reporter | Street | 120 | 100 |
3 | Literary Citations | 829 | 500 |
4 | Product | Key Ingredient | 120 | 100 |
5.1 | Regulatory Authorities | Local Company Contact | Title | 40 | 10 |
5.2 | Regulatory Authorities | Local Company Contact | Contact Name (Family Name) | 40 | 35 |
5.3 | Regulatory Authorities | Local Company Contact | Address | 120 | 100 |
5.4 | Regulatory Authorities | Local Company Contact | Fax | 50 | 10 |
5.5 | Regulatory Authorities | Local Company Contact | Phone | 20 | 10 |
5.6 | Regulatory Authorities | Agency Information | Title. | 40 | 10 |
5.7 | Regulatory Authorities | Agency Information | Contact Name | 40 | 35 |
5.8 | Regulatory Authorities | Agency Information | Address | 120 | 100 |
5.9 | Regulatory Authorities | Agency Information | Phone | 20 | 10 |
5.10 | Regulatory Authorities | Agency Information | Fax | 50 | 10 |
6 | Code List | Licenses | License Information | Number | 40 | 35 |